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USDA • FSIS
Improving the
Safety of
Meat and Poultry
'i j|7l
on
Science'hased
Strategy for
Protecting
Public Health
Document Delivery Services Branch
USDA, National Agricultural Library
Nal BIdg.
10301 Baltimore Blvd.
Beltsville. MD 20705-2351
National Agricultural Library
tMk^aStatms Offictof N»ws Distribution
Otpartmmii of Communications Boom 506-A
AgrietiKun Washington, D.C. 20250
Release No. 0072.95
Mary Dixon (202) 720-4623
Jacque Knight (202)720-9113
USDA UNVEILS SWEEPING NEW FOOD SAFETY PROPOSALS
WASHINGTON, Jan. 31, 1995- -The U.S. Department of Agriculture today
proposed sweeping changes in federal meat and poultry inspection, from a
system based primarily on sight, touch and smell to one incorporating
scientific testing and systematic prevention of contamination.
"These reforms demonstrate this administration's strong commitment to
making meat and poultry safer for consumers , " said Acting Secretary Richard
Rominger at a press conference announcing a thorough modernization of USDA's
food safety procedures.
"In keeping with the President's initiative to reform the way the
federal government does business, we propose to reinvent the meat and poultry
inspection system by incorporating science -based concepts to make our food
supply safer. This initiative is not about more regulation. It's about
better, more sensible regulation."
"We are proposing a system that would directly target and reduce harmful
bacteria and build prevention of foodbome illness into meat and poultry
inspection," said Michael R. Taylor, the acting under secretary for Food
Safety and administrator of USDA's Food Safety and Inspection Service (FSIS) .
"These proposals mark a fundamental shift. They are targeted to improve
the safety of meat and poultry products by directly addressing the pathogenic
microorganisms that cause most food- related illnesses and by increasing our
ability to ensure that all meat and poultry companies follow sound food safety
procedures," Taylor said.
The proposal would require the nation's nearly 6,200 federally inspected
meat and poultry slaughter and processing plants to adopt science -based
process control systems, called Hazard Analysis and Critical Control Points
(HACCP) . The HACCP systems would identify potential food safety hazards
arising in slaughter and processing plants and build in science-based
preventive controls. USDA's food safety proposals would also affect about
2,900 state inspected plants and foreign meat and poultry inspection programs,
which under current law must be equivalent to the U.S. system.
Under the HACCP proposal, industry would verify the effectiveness of
their operations by continuous monitoring of the controls, end product testing
and careful record keeping. FSIS, the agency responsible for designing and
carrying out USDA's food safety program, would review each plant's records
and conduct other in-plant inspection activities to verify that proper food
safety procedures are being followed.
For the first time, targets would be set for reducing the incidence of
contamination of raw meat and poultry products with harmful bacteria. Plants
MEWS
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that do not achieve established targets for pathogen reduction within a
specified time would be required to take corrective action under FSIS
supervision to achieve the target.
The proposal would require slaughter plants to test raw products
initially for Salmonella , a pathogenic bacteria that is the most common cause
of foodborne illness in the United States. The proposal includes identifying
the current baseline incidence of Salmonella contamination for each major
species and for ground meat and poultry. Slaughter plants would be required
to reduce contamination to a level determined after FSIS reviews comments on
the proposed rule. The proposal would require bacterial testing 90 days after
publication of the final rule.
"The HACCP system clearly establishes the meat and poultry industry's
responsibility for improving the safety of their products, and the interim
targets will help achieve measurable progress toward pathogen reduction even
as we develop our HACCP program." said Taylor, who was appointed the
administrator of the Food Safety and Inspection Service in August and in
October was named to the new position of acting under secretary for food
safety.
"Our proposals will stimulate the innovative capacity of the meat and
poultry industry to produce safer products," Taylor added. To facilitate the
innovations, FSIS is reviewing its existing food safety regiilations and will
delete requirements that are obsolete or unnecessarily inhibit the
incorporation of science -based preventive controls into meat and poultry
production systems.
The new proposal also includes basic food safety procedures that Taylor
says many plants have already implemented, including written sanitation plans,
antimicrobial treatments and strict temperature controls for raw products .
USDA estimated the total implementation cost of the proposal to the meat
and poultry industry at $733.5 million over three years, or an average of
$24A.5 million per year. Yearly public health benefits from reduced foodborne
illness costs, including medical care and lost work time, would range from
$990 million to $3.7 billion. These costs amount to slightly more than two
tenths of a cent per pound.
According to Rominger and Taylor, the proposals to improve in-plant food
safety procedures are part of a broad USDA food safety strategy that will
stress preventive measures throughout the food chain.
"We will be working cooperatively with the producer community to find
and implement solutions to food safety problems on the farm, and we will work
jointly with FDA to ensure that appropriate food safety controls are in place
during the transportation process," Taylor said. "We are also expanding our
collaboration with the states to improve food safety at the retail level."
Noting that consumers also share the responsibility for the safety of
their food, Taylor added, "As USDA works to do a better job to protect
consumers, it is critical that consumers do their part by properly handling
and cooking meat and poultry products."
FSIS plans extensive public outreach during the 120 -day comment period
to explain and receive comments on the proposal.
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"It is only with the iaeas , views and input of all interests that we can
develop the best inspection system possible. We want to stimulate dialogue and
draw out informed and constructive comments so we can make this proposed rule
effective and workable. All parties, government and industry, consumers and
the scientific community, need to work together to improve the safety of meat
and poultry," Taylor said.
The proposed USDA HACCP/Pathogen Reduction rule is scheduled to be
publish in the Feb. 3 Federal Register. Comments will be accepted through
June 5. Comments can be sent to: Policy, Evaluation and Planning Office,
Attn: Diane Moore, FSIS Docket Clerk, Room 3171-South Building, Food Safety
and Inspection service, U.S. Department of Agriculture, Washington, D. C.
20250.
The USDA proposals for HACCP and pathogen reduction are the latest steps
taken by the Administration to strengthen and update the federal inspection
program for meat and poultry products. Initiatives since January 1993
include :
started unannounced reviews in 1,000 meat and poultry plants,
-- implemented mandatory safe cooking and handling instruction on labels
of meat and poultry products ,
increased funding for food safety research,
-- elevated food safety to a sub-cabinet level at USDA,
-- declared E.coli 0157 :H7 in raw ground beef an illegal adulterant,
-- initiated a sampling program for raw ground beef, and
-- streamlined approval of antimicrobial treatments for use by industry.
U S DEPT. OF AGRICULTURE
NATIONAL AGRICULTURAL LiBRARY
FEB 1 3 1996
CATALOGING PREP.
p FSIS Pathogen
Reduction ^'HACCP
^'m^hi Proposal
SUMMARY
The Food Safety and Inspection Service (FSIS) is pur-
suing a broad, long term science-based strategy to im-
prove the safety of meat and poultry products and bet-
ter protect public health.
The strategy will address food safety issues from the
farm to the table, including proposed requirements for
all federally inspected meat and poultry plants to re-
duce pathogenic microorganisms that can cause
foodborne illness. The strategy is based on the phi-
losophy of prevention embodied in HACCP (Hazard
Analysis and Critical Control Points), a science-based
system for producing safe food.
The regulatory proposal would (1 ) target pathogens that
cause foodborne illness; (2) strengthen industry respon-
sibility to produce safe food; and (3) focus inspection
and plant activities on prevention objectives.
The proposal addresses three major areas:
Near-term initiatives
FSIS is proposing that:
• All plants develop and use written standard
operating procedures covering plant sanitation.
• Slaughter plants use at least one antimicrobial
treatment on all carcasses.
• All finished carcasses and parts be chilled promptly
after slaughter and be kept cool.
These requirements would have to be implemented
within 90 days from the date of publication of the final
rule and would remain in effect at least until a Hazard
Analysis and Critical Control Points (HACCP) system is
implemented.
Proposed Interim Targets for Pathogen
Reduction and l\/licrobial Testing
Under the proposal, FSIS would establish interim tar-
gets for pathogen reduction and require daily microbial
testing in slaughter plants to determine whether targets
are being met or remedial measures are necessary.
Raw products would be tested for Salmonella, a repre-
sentative pathogen, and establishments would be re-
quired to achieve targeted reductions in the incidence
of Salmonella in relation to the current national baseline
incidence. Microbiological testing would be required
to begin in 90 days and tracking of test results would
begin 6 months after the final rule is published. Com-
pliance with the interim targets would be determined
by using a moving sum statistical procedure that fo-
cuses on a specific number of days within a production
process.
Hazard Analysis and Critical
Control Points (HACCP)
All plants would be required to develop, adopt, and
implement Hazard Analysis and Critical Control Points
(HACCP), a system of preventive controls designed to
improve the safety of products. HACCP would be imple-
mented during the three years following the publica-
tion of the final rule. FSIS expects the near-term initia-
tives and microbial testing requirements to provide the
foundation for the later adoption of HACCP by plants.
Implementation Costs
FSIS estimates the total implementation cost of its pro-
posed requirements to the meat and poultry industry at
$733.5 million, or an average of $244.5 million per year.
Yearly public health benefits from reduced foodborne
illness costs, including medical care and lost work time,
would range from $990 million to $3.7 billion. The in-
creased cost to consumers is estimated at slightly more
than two tenths of a cent per pound.
Comments
The proposed USDA HACCP/Pathogen Reduction rule
was published in the February 3 Federal Register,
Comments on the proposal should be submitted to
Diane Moore, Docket Clerk, Room 3171 South Build-
ing, Food Safety and Inspection Service, U.S. Depart-
ment of Agriculture, Washington DC 20250. Comments
will be accepted through June 5.
February 1995
U.S. Dcparlment of AgricLillurc
Food Safely & Inspection Service
BACKGROUND
Current FSIS regulatory requirements and inspection
procedures contribute to tlie FSIS mission of ensuring
that meat and poultry products are safe, wholesome,
and accurately labeled. More than 7,400 FSIS inspec-
tors are present in 6,200 slaughter and processing
plants to ensure that diseased animals and birds do
not enter the food supply and that sanitation and other
requirements are met. Inspectors also monitor the meat
and poultry supply for violative levels of chemical resi-
dues.
Despite the successes of the current program, there is
a critical gap in its ability to protect public health. The
current system largely focuses on organoleptic (sen-
sory) inspection, which was appropriate when the first
major meat inspection law was passed in 1 906. At that
time, animal diseases were the major concern, and in-
visible hazards such as pathogenic microorganisms and
drug residues had not yet attracted the attention of regu-
latory agencies. Since that time, changes have been
made in the inspection program to reflect changes in
the production of meat and poultry and to increase the
efficiency of inspection. However, the current program
still is inadequate to detect hazards such as pathogenic
microorganisms that can cause foodborne illness. In
short, it does not include integration of systematic pro-
cess control into the production process to make meat
and poultry as safe as possible.
While precise data on the incidence of illness associ-
ated with meat and poultry products is limited, it is clear
that foodborne illness is a public health problem in the
United States. Data from varied sources suggest that
foodborne pathogens account for up to 7 million cases
of foodborne illness each year, and up to 7,000 deaths.
Of these, nearly 5 million cases of illness and more
than 4,000 deaths may be associated with meat and
poultry products.
Microbiological surveys of meat and poultry products
conducted over the past several decades show the fre-
quency of pathogenic microorganisms in cooked, ready-
to-eat meat and poultry products to be relatively low.
The frequency of pathogenic microorganisms in raw
products has been greater and varies from pathogen
to pathogen and from species to species.
Even when the incidence of contamination is relatively
low, the public health threat can be serious. An ex-
ample is the outbreak of foodborne illness that occurred
in several western states in early 1993. The outbreak
was attributed to undercooked hamburgers contami-
nated with E. CO// 01 57:H7 that were served at a chain
of fast food restaurants. A study by FSIS completed in
1990 found the prevalence of E. co// 01 57:H7 in raw
beef to be only 0.1 percent. Nevertheless, this particu-
lar outbreak led to hundreds of cases of illness and
four deaths. Although the Department of Agriculture's
review of the outbreak revealed that the incident was
not caused by a failure in the current inspection sys-
tem, it concluded that the system as it exists is defi-
cient because it does not adequately address the risk
of microbial contamination.
This conclusion has been supported by many external
studies conducted during the past decade. The Na-
tional Academy of Sciences, the General Accounting
Office, the National Advisory Committee on Microbio-
logical Criteria for Foods, industry, producers and con-
sumer groups have called for change in the current in-
spection system to better address microbial pathogens
and make it more prevention-oriented.
FSIS Strategy
• Stimulate improvement in food safety prac-
tices by setting public health-oriented targets,
guidelines, or standards that all plants must
meet.
• Clearly define the minimum requirements all
plants must meet to produce safe meat and
poultry and ensure that plants are account
able for meeting them.
• Make meat and poultry plants responsible
for microbial testing of their products to en-
sure proper process control and verify
achievement of microbial limits.
• Foster scientific and technological innovation
within the meat and poultry industry by remov-
ing any unnecessary regulatory obstacles to
innovation.
• Build the principle of prevention into the
operations of meat and poultry plants.
• Focus inspection on prevention objectives.
• Approach the food safety mission broadly and
consider potential hazards that arise through-
out the food production and delivery system,
including before animals enter FSIS-inspected
plants and after meat and poultry products
leave those plants.
2
THE PROPOSAL
Near-Term Initiatives
• Sanitation Standard Operating
Procedures (SOPs)
Insanitary conditions during the production of meat and
poultry products increase the likelihood that pathogenic
bacteria will contaminate the finished product. At the
same time, poor sanitation is the most frequently ob-
served problem in meat and poultry plants.
FSIS is proposing to require all plants to establish writ-
ten SOPs for sanitation and maintain a system of
records to document adherence to the procedures. The
proposal does not change existing basic sanitation re-
quirements found in the regulations or guidance con-
tained in the FSIS Sanitation Handbook. Rather, the
written sanitation SOPs would describe the specific
activities plant management has determined are nec-
essary to maintain good sanitation in a specific plant.
Examples of specific practices that might be included
in an SOP include pre-operational microbiological test-
ing, disinfection of equipment prior to start up, proper
hand washing between each carcass during skinning
and evisceration, and cleaning cattle prior to slaughter.
Sanitation SOPs are intended to clarify that sanitation
is industry's responsibility. They would make it easier
for FSIS inspectors to perform their proper role of veri-
fying that plant management is carrying out its sanita-
tion responsibilities.
• Antimicrobial treatments
The proposed regulation would require that slaughter-
ing plants apply at least one antimicrobial treatment to
livestock and poultry carcasses before chilling or cool-
ing. FSIS recognizes that this is not a complete solu-
tion to the problem of pathogenic microorganisms but,
rather, is one part of a strategy to reduce pathogens.
For the purposes of this regulation, FSIS would approve
specific antimicrobial treatments when data are avail-
able demonstrating that they are safe and effective and
do not adulterate the product. The following are avail-
able antimicrobial treatments that FSIS tentatively con-
cludes could satisfy its proposed requirements for a
mandatory antimicrobial treatment: hot water; lactic,
acetic, and citric acid solution sprays; trisodium phos-
phate; and chlorinated water. The Agency encourages
the development of new antimicrobial procedures and
will work with those who have developed and want to
evaluate processing techniques designed to enhance
product safety.
Antimicrobial treatments will not be allowed to substi-
tute for careful sanitary dressing procedures. This new
proposed requirement would not change the current
FSIS policy regarding removal of physical contaminants
from meat and poultry carcasses. The proposal clari-
fies that there is no tolerance for feces on poultry car-
casses.
• Time/Temperature Controls
Rapidly cooling carcasses is one means of preventing
the multiplication of pathogenic bacteria. FSIS is pro-
posing that appropriate time/temperature controls for
handling raw products, which many plants follow vol-
untarily based on prevailing industry standards, become
mandatory.
Plants would be required to cool the surface of meat
carcasses to 50° F or below within 5 hours and to 40° F
or below within 24 hours from the time that carcasses
exit the slaughter floor. In addition, carcasses and meat
products would be required to be maintained at 40° F
or below during handling, holding, and shipping.
Current poultry regulations already require that all poul-
try slaughtered and eviscerated be chilled immediately
after processing so that the internal temperature is re-
duced to 40° F or below within a time period appropri-
ate for the size of the carcass. Eviscerated poultry to
be shipped must be maintained at 40° F or below, with
certain exceptions. FSIS is proposing to amend the
poultry regulations to include provisions for alternative
time/temperature requirements, to mandate corrective
actions when time/temperature controls fail, and to elimi-
nate other provisions inconsistent with those being pro-
posed for meat.
The proposed time/temperature cooling requirements
for meat are equivalent to those in effect and being
proposed for poultry in terms of their public health ben-
efits and are readily attainable under current commer-
cial conditions.
Plants would be required to develop, implement, and
file a written plan for meeting the time and temperature
requirements. Inspection personnel would verify that
the written plan is being followed and would measure
temperatures at various control points and compare
them with those measured and recorded by the plant.
3
Products that are not chilled quickly enough, or that
have been held at temperatures exceeding 40° F, would
be required to be further processed to l<ill pathogens or
be condemned.
Interim Targets for Pathogen Reduction
and Microbial Testing
FSIS believes that the production of raw meat and poul-
try with an incidence of Salmonella below the current
national incidence level is readily achievable with avail-
able technology and production methods. FSIS is pro-
posing that all plants should be required to control their
processes to achieve microbial targets below the na-
tional incidence level, and is therefore proposing in-
terim targets for pathogen reduction in slaughter plants.
Under the proposal, plants would be required to sample
and test representative products daily for the presence
of Salmonella. FSIS would identify a national baseline
incidence of Sa/mone//a contamination for each major
species and for ground meat and poultry. FSIS is pro-
posing that within two years following the publication
of the final rule, or within some other period specified
by FSIS, all plants reduce contamination below the
baseline, perhaps by some specified percentage. FSIS
is interested in comments on what that percentage
should be.
This is an initial step toward measurable reductions in
microbial contamination and a first step toward the even-
tual incorporation of microbial testing as an integral part
of process control and verification in plants operating
under the HACCP approach. FSIS intends to work to-
ward setting more definitive targets, guidelines, or stan-
dards, including the possible identification of levels of
specific pathogens that pose a safety concern and the
use of those levels for regulatory purposes. Even as
the scientific basis for such standards develops, how-
ever, FSIS believes that significant reductions in the
risk of foodborne illness can be achieved by requiring
compliance with interim targets for pathogen reduction.
Salmonella was selected as the target pathogen be-
cause it is the leading cause of foodborne illness, it is
present on virtually all raw food products, and it can
easily be recovered from a variety of products. Reduc-
tions in Salmonella should also result in reductions of
other human pathogens.
Each plant would be required to develop a written pro-
tocol, available for review by the inspector in charge,
outlining specimen collection and handling.
The results would be entered into a moving sum pro-
cess control table or chart, which provides immediate
feedback on the effectiveness of the control system.
Plants that are not achieving the established targets
for pathogen reduction within the period specified by
FSIS would be required to take corrective action under
FSIS supervision to improve process control to achieve
the target.
Hazard Analysis and Critical
Control Points (HACCP) Systems
FSIS is proposing that federally inspected meat and
poultry plants adopt HACCP systems to provide docu-
mentation that their processes are in control and pro-
ducing safe products. The HACCP approach is a pre-
ventive system of process control that is widely recog-
nized by scientific authorities and international organi-
zations and is used in the food industry to produce prod-
uct in compliance with health and safety requirements.
Implementation of HACCP would clarify that the indus-
try, not the inspection service, is responsible for pro-
ducing safe meat and poultry products. With HACCP
in place, FSIS would verify that the plant is controlling
its processes and consistently producing products that
comply with food safety requirements.
HACCP systems would cover those critical control
points (CCP's) that affect product safety, as opposed
to those related to economic adulteration and quality.
A HACCP plan would be required for each type of pro-
cessing activity carried out by the plant. FSIS would
not approve HACCP plans in advance but would evalu-
ate their effectiveness as part of the inspection pro-
cess.
Plants would be required to develop HACCP plans
based on the seven principles articulated by the Na-
tional Advisory Committee on Microbiological Criteria
for Foods:
(1 ) Conduct a hazard analysis;
(2) Identify the CCP's in the process;
(3) Establish critical limits for preventive
measures associated with each identified
CCP;
(4) Establish CCP monitoring requirements;
4
(5) Establish corrective action;
(6) Establish effective recordkeeping
procedures; and
(7) Establish procedures for verifying that the
HACCP system is working correctly.
Implementation would be phased in, based on the type
of production process. It is proposed that implementa-
tion for processes associated with the greatest public
health risk would begin 12 months after publication of
the final rule. Implementation would be complete 36
months after publication of the final rule. Small estab-
lishments, which FSIS is proposing to define as those
with an annual production valued at or below $2.5
million, would be permitted 36 months from the date of
publication of the final rule to start their HACCP plans,
regardless of the processes they carry out.
Food Safety from Farm to Table
The proposed regulations address product safety only
within the plant environment. The Agency recognizes
that ensuring food safety requires taking steps through-
out the chain of production, processing, distribution, and
sale to prevent hazards and reduce the risk of foodborne
illness. To minimize the growth of pathogens once a
product leaves the plant, FSIS is announcing its intent
to initiate rulemaking with the Food and Drug Adminis-
tration (FDA) to establish Federal standards for the safe
transportation of foods. FSIS will also work with FDA
to ensure food safety at the retail level by encouraging
States to adopt and enforce consistent, science-based
standards.
Although animal production food safety is not the sub-
ject of this regulatory proposal, FSIS also will work with
animal producers and others to develop and implement
food safety measures that can be taken on the farm
and before animals enter the slaughter facility to re-
duce the risk of harmful contamination of meat and
poultry products.
In addition, the Agency will continue its comprehensive
food handler education programs to inform the public
and those who prepare and serve food to the public on
how to properly handle, prepare, and store meat and
poultry products to minimize the growth of foodborne
pathogens.
Health-Based Standards for
Pathogenic Microorganisms
The proposed requirement that plants achieve a cer-
tain reduction in the incidence of Salmonella is an ini-
tial step toward articulating an acceptable level of food
safety performance. The broader task of identifying
levels of specific pathogens that pose a threat to public
health is complex. FSIS intends to hold one or more
public meetings to explore this and other topics with
interested parties and intends to work closely with gov-
ernment and public health agencies, academia, indus-
try, and consumer groups to develop the scientific ba-
sis for microbial risk assessment and health-based
performance standards for pathogenic microorganisms.
Technology Development
Because the development and proper use of technol-
ogy can contribute significantly to improving the safety
of the food supply, FSIS is encouraging technology
development in several ways. First, by setting public
health standards, the Agency believes it is providing a
heightened incentive to take innovative steps to improve
food safety. Second, FSIS will review its policies and
procedures governing the review and approval of in-
plant technologies to simplify them as much as pos-
sible, while ensuring that safety and efficacy are not
compromised. Third, FSIS will focus its own limited
technology development resources on tools that can
assist the Agency in detecting and evaluating food
safety hazards and on research that requires a long-
term commitment.
FSIS Inspection Roles
FSIS must consider the future roles of its inspection
force. FSIS intends to work closely with the bargaining
unit and employee organizations in formulating its plan
for inspection under HACCP. FSIS must consider a
number of issues, including
(1) what additional tasks FSIS inspectors
should be performing under HACCP,
(2) what the role of FSIS inspectors should
be in ensuring that Federal standards are
met during transportation and at the retail
level, and
(3) what new inspection tools and techniques
are needed in a regulatory environment
where greater responsibility for safety is
being placed on industry.
5
Administration Food Safety Initiatives
These initiatives build on a number of important steps
already undertaken by the Administration to strengthen
and update the Federal inspection program for meat
and poultry products. They include:
(1 ) the elevation of food safety to a sub-Cabi-
net-level responsibility within the Depart-
ment of Agriculture,
(2) development of pathogen reduction leg-
islation to target microbial pathogens in
meat and poultry products and reduce the
risks of foodborne illness,
(3) declaration of E. co// 01 57:H7 in raw
ground beef to be an illegal adulterant and
initiation of a sampling program for raw
ground beef.
(4) streamlined approval of antimicrobial
treatments to help the beef industry move
faster to install new technologies to reduce
pathogens;
(5) initiation of unannounced reviews in 1 ,000
meat and poultry plants to enforce inspec-
tion requirements,
(6) implementation of mandatory safe
handling instructions on labels of meat
and poultry products, and
(7) increased funding for food safety
research.
To obtain paper or disltette copies of the proposal contact:
National Technical Information Service (NTIS)
U. S. Department of Commerce
5285 Port Royal Road
Springfield, VA 22161
(Reference NTIS accession number PB95- 1 6602 1 for a paper copy
and PB95-502217 for the diskette version).
For telephone orders or further information on placing an order, call NTIS at (703) 487-4650
for regular service or (800) 533-NTIS for rush service.
To order the proposal electronically and download via FedWorld, dial (703) 321-8020
with a modem or Telnet fedworld.gov. For technical assistance to access FedWorld, call (703) 487-4608.
For more information
Technical Inquiries: (202) 720-7773
Media Inquiries: (202) 720-91 1 3
Congressional Inquiries: (202) 720-3897
Constituent Inquiries: (202) 720-7943
Consumer Inquiries:
Call USDA's Meat and Poultry Hotline at: 1 -800-535-4555
In the Washington, D.C. area, call: (202) 720-3333
6
/ A Fann-to-Table
y// , . _ Food Safety Strategy
The Food Safety and Inspection Service (FSIS) Is
pursuing a broad, long term science-based strategy to
address food safety from the farm to the table. The
strategy expands the agency's food safety mission to
consider potential hazards throughout the food
production and delivery system. The strategy is open
to public comment for 120 days, and FSIS will actively
seek ideas of consumers, scientists, employees and
industry.
The inspection laws FSIS administers focus on
activities inside federally inspected meat and poultry
plants to ensure product entering into commerce is
unadulterated and properly labeled. To improve the
safety of meat and poultry products produced in these
plants, FSIS is proposing pathogen reduction and
Hazard Analysis and Critical Control Points (HACCP)
measures to reduce the levels of pathogenic
microorganisms on meat and poultry products and the
incidence of foodborne illness associated with these
products. As part of its food safety strategy and public
health mandate, FSIS will continue to educate
consumers about safe food handling practices to
reduce the risk of food poisoning. FSIS is also working
with the animal production, transportation, distribution
and retail sectors of the food industry to ensure the
whole system Is working effectively to prevent food
safety problems.
Proposed in-piant activities
• FSIS is proposing new near-term and long-term
requirements to establish systematic, preventive
measures to eliminate and reduce the presence of
pathogenic microorganisms in meat and poultry
products. Under the proposal, near-term
requirements would be implemented within 90 days
of the publication of a final regulation:
— All plants would develop and use written standard
operating procedures for plant sanitation.
— Slaughter plants would use at least one
antimicrobial treatment to reduce the levels of
pathogenic microorganisms on carcass surfaces.
— All plants would have to follow proposed time and
temperature requirements for chilling finished
carcasses and parts after slaughter.
• FSIS would establish interim targets for pathogen
reduction and mandate daily microbial testing in
slaughter plants to ensure targets are being met.
Microbiological testing would be required 90 days
after a final regulation is published.
• FSIS would require all plants to develop and
implement HACCP systems to identify and prevent
microbial and other hazards in food production.
HACCP would be implemented over a three year
period.
• While FSIS new regulatory proposal focuses on in-
plant activities, the agency recognizes that measures
to ensure the safety of meat and poultry products
must be taken at all stages of animal production,
slaughter, processing, distribution, sale and
preparation.
On-farm activities
• FSIS will work closely with academic researchers,
other government agencies, producer groups, and
consumer organizations to help shape an
appropriate research agenda and devise effective
on-farm food safety strategies.
• Better animal husbandry and on-farm hazard control
measures such as sanitary bedding offer the
potential to reduce or eliminate pathogenic bacteria
on food animals.
• FSIS will work with animal producers and others to
develop and put into place voluntary food safety
measures, such as voluntary quality assurance
systems with built in steps to prevent potential
contamination of live animals.
Retail and transportation activities
• FSIS monitors food products in commerce after they
leave inspected facilities to ensure compliance with
laws prohibiting adulteration or misbranding of food.
January 1995
U.S. Department of Agriculture
Food Safety & Inspection Service
However, state and local governments provide most
of the resources devoted to overseeing the safety of
food during transportation to and sale from retail
establishments.
• FSIS will encourage States to adopt and enforce
science-based standards consistent with those the
agency is proposing to ensure food safety at the retail
level.
• FSIS is reviewing the effectiveness of its program in
the area of transportation of meat and poultry
products, and handling and preparation of products
by retail stores, restaurants and institutions.
• FSIS will continue to work jointly with the Food and
Drug Administration (FDA) to establish federal
standards for safe handling of food during
transportation, distribution, and storage prior to
delivery to retail stores.
• The agency is working in conjunction with FDA in
the following two areas:
(1) FSIS continues to work closely with FDA in
providing food safety guidance to retail stores, most
recently in the publication of the updated Food Code ,
which FSIS and FDA will encourage the States to
adopt. The Food Code is a model ordinance
intended to serve as a guide for State and local
authorities, who have primary jurisdiction over retail
stores and restaurants.
(2) FSIS and FDA have recently agreed to work
together to develop guidelines for conveyances used
to transport food products and to engage in joint
rulemaking on standards to ensure food safety during
transport.
Food safety education
• FSIS will continue its comprehensive consumer
education programs to inform the public on how to
properly handle, prepare, and store meat and poultry
products to minimize the growth of foodborne
pathogens.
For technical information, call
Judith Segal (202) 720-7773
January 1995
ProjX)sccl wSanitalioii
Standard Operating
/ Procedures
Good sanitation is a fundamental requirement of federal
meat and poultry inspection laws and is necessary for
safe food production. Yet, poor sanitation practices,
such as improper cleaning of facilities and equipment,
are the most frequent deficiencies found in some meat
and poultry plants. There is a direct and substantial
link between insanitary practices in meat and poultry
plants and the likelihood of product contamination with
pathogenic bacteria.
Sanitation Standard Operating Procedures (SOPs) are
one of the near-term requirements FSIS is proposing
as part of its strategy to reduce the incidence of
pathogens in meat and poultry products. FS/S w/7/
actively seek the ideas of consumers, employees
scientists and industry. The proposed SOPs would
become effective 90 days from publication of a final
rule.
• USDA is proposing that federally inspected meat and
poultry plants develop written sanitation SOPs to
show how they meet basic sanitation requirements
every day.
• Meat and poultry plants would document and
maintain daily records or checklists of completed
sanitation procedures, and make them available to
the USDA inspector for review and verification.
• The proposal would institute a process to ensure
better compliance with existing federal sanitation
requirements. It would not impose new sanitation
requirements.
• Recent FSIS unannounced reviews of 1,000
federally inspected meat and poultry plants found
more frequent and serious deficiencies in sanitation
than in other areas examined.
• Traditionally, some federally inspected meat and
poultry plants have relied heavily on inspectors to
identify deficiencies on a daily basis.
• Under the proposed changes, the initial respon-
sibility for identifying and addressing sanitation
deficiencies in each plant would be clearly placed
on the plant.
• Inspectors would verify that plants are complying with
sanitation SOPs, while continuing to directly observe
conditions in the plant.
• SOPs would include, but not be limited to,
procedures the plant would conduct to prevent
contamination before and during operation that can
result in product adulteration.
• If sanitation SOPs are not followed, USDA would
take appropriate actions to ensure no product is
produced under insanitary conditions.
For technical information, call
Isabel Arrington (202) 720-7905
January 1995
U.S. Dcpartiiicnl of AgriciilUirc
FcH)d Safely t'<i Inspcciit)n Service
p^/ Proposed Time and
^y^ii,,^^ Temperature Controls
Temperature is one of the primary factors affecting the
increase of bacteria in raw products. Pathogenic
bacteria on raw meat and poultry products multiply
rapidly at warm temperatures, over time. However,
virtually all pathogenic bacteria stop multiplying at 40
degrees Fahrenheit (F) or below. Therefore, the soorier
raw product can be chilled to and maintained at that
temperature, the less likely any pathogens present will
multiply to hazardous levels in the finished product.
Time and temperature controls are one of the near-
term requirements USDA is proposing to reduce the
risk of hazardous levels of pathogens in raw meat and
poultry products reaching consumers. This regulatory
process control would become effective 90 days from
publication of a final regulation. FSIS will actively seek
the ideas of consumers, employees, scientists and
industry.
• USDA would require meat and poultry plants to
develop a written plan for meeting time and
temperature requirements specified in the
regulations.
• To minimize the growth of pathogenic
microorganisms, the proposed rule would require
plants to chill carcass surfaces and hot-boned
meat — which is meat removed from bone before the
carcass cools — to 50 F (10 degrees Celsius) within
5 hours and then to 40 F (4.4 C) within 24 hours of
slaughter or meat and bone separation. Meat
products such as liver and cheek meat would begin
chilling within one hour of removal from the carcass.
Raw meat and poultry products would be maintained
at 40 F or below to prevent any pathogenic bacteria
that may be present on the surface of the raw
products from multiplying.
• The proposed action would make poultry cooling
requirements consistent with those for meat. The
cooling rates for poultry carcasses would be based
on the surface temperature rather than the weight of
the bird. Faster cooling rates for poultry would be
based on wetness of the product since wetness
facilitates rapid bacterial growth.
• Chilling is required of all raw product unless it moves
directly from the slaughter line to heat processing,
which destroys pathogens.
• Raw products would be shipped to other plants at
40 F or below and maintained at that temperature.
• Raw products that have not been chilled and held at
specified times and temperatures would require
further processing to kill pathogens or be
condemned.
• The proposed time and temperature requirements
would be well within the parameters of customary
and usual industry chilling practices used to inhibit
growth of spoilage bacteria.
• The proposed requirements would be new only for
plants producing raw meat because comparable
requirements already exist for poultry.
For technical information, call
Carl Custer (202) 501-7321
January 1995
U.S. Department ol" Agrieulture
Food Safety & Inspeetion Service
Proposed
Antimicrobial
Treatments
Despite the best efforts to reduce or eliminate
contamination during slaughter and processing,
pathogenic bacteria still may be present on livestock
and poultry carcasses.
• e * e «
products. The proposed regulatory requirement would
go into effect 90 days from the publication of a final
regulation. FSIS will actively seek the ideas of
consumers, employees, scientists and industry.
Antimicrobial treatments are one of the near-term
requirements USDA is proposing to reduce the
incidence of pathogens in raw meat and poultry
• The proposal would require every federally inspected
meat and poultry slaughter plant to treat fresh
carcasses with a process shown to reduce
pathogenic bacteria on carcass surfaces.
• To reduce spoilage and other bacteria, many meat
and poultry plants have incorporated antimicrobial
treatments or "interventions" into their slaughter
operations that have been shown to greatly reduce
the levels of any bacteria that may be present.
• Requiring all federally inspected slaughter plants to
employ at least one such treatment will not, by itself,
solve the problem of contamination with pathogenic
bacteria, but is one step among many that can
reduce the risk of raw product reaching the consumer
with hazardous levels of pathogenic bacteria.
• Antimicrobial treatments will not be permitted to
substitute for strict compliance with sanitary
slaughter and carcass dressing procedures; e.g., no
visible fecal contamination will be permitted on the
carcass before the treatment is applied.
• Three kinds of antimicrobial treatments have been
shown to substantially reduce bacteria levels and
are being authorized for use to meet the proposed
requirement:
(1) Hot water, applied so that the temperature of
the water on the carcass surfaces is at least 1 65
degrees Fahrenheit (F) (74 degrees Celsius) for at
least 10 seconds;
(2) Use of antimicrobial compounds, as approved
for use in FSIS regulations or in Food and Drug
Administration regulations with FSIS's approval
(These compounds currently include use of lactic,
acetic and citric acid sprays on meat or poultry
carcasses, and trisodium phosphate sprays on
poultry carcasses.); and
(3) Use of chlorinated water as a final carcass wash.
Chlorinated water is currently the most commonly
used intervention.
• FSIS is encouraging the development of other
treatments that will have similar or better
antimicrobial effects.
For technical information, call
Bill James (202) 720-3219
January 1995
U.S. Dcparlmciil of Agriculture
Food Safely & Inspection Service
■ Proposed Microbial Testing
f./' iind Interim Targets for
^^.- '' '"^ Pathogen Reduction
FSIS is proposing to set interim targets for pathogen
reduction and to require microbial testing as a means
of reducing the Incidence of pathogenic microorganisms
on meat and poultry products.
The proposed actions are first steps toward requiring
all meat and poultry plants to set up Hazard Analysis
and Critical Control Points (HACCP) systems, which
Include end-point microbial testing to verify the
effectiveness of control systems in preventing microbial
contamination.
Microbiological testing would be required 90 days after
publication of the final rule. Plants would begin tracking
of test results 6 months after the rule Is published. FSIS
will actively seek the ideas of consumers, employees,
scientists and industry on its proposal.
• FSIS proposes to set microbiological criteria to define
acceptable performance by a meat or poultry plant
and to hold the plant accountable for achieving at
least that level of performance.
• Under the proposal, plants would conduct microbial
testing, at least once a day, for Salmonella. Test
results over time could be used to verify that the plant
has Its production processes under control or to show
whether remedial measures are needed.
• Salmonella was selected as a target organism for
several reasons in addition to its being the most
commonly reported cause of foodborne Illness linked
to meat or poultry products.
• Interventions that reduce Salmonella levels have
comparable effects against most other foodborne
pathogens from animals Intestines; methods are
available to recover the organisms from a variety of
meat and poultry products; and FSIS baseline
studies suggest that It colonizes in a variety of
animals and birds frequently enough for detecting
and monitoring changes.
• The goal Is for all plants to produce meat and poultry
products with Salmonella occurring no more
frequently than at the national baseline average.
• Each plant would develop a written protocol for
sampling, which would be available for review by
the Inspector-ln-Charge.
• For meat, samples would be collected before
carcasses leave the cooler; for poultry. Immediately
after the birds leave the chiller; and for raw ground
meat and poultry, specimens would be collected
before the products are packaged and frozen.
• Plants could test for Salmonella In their own
laboratories or In a commercial/contract laboratory
with demonstrated experience in testing meat and
poultry for Salmonella .
• Laboratories would be required to make their quality
control records available to FSIS upon request to
verify their capability, and they would have to provide
daily test results to plants.
• Plants are responsible for analyzing their own data
and would have to make data available to Inspection
personnel.
• The data would be evaluated using a "moving sum
procedure" in which the number of positive samples
obtained over a set time period are totaled.
• The sums could not exceed acceptable limits
proposed for each species and for raw ground
products. The procedure Is spelled out In the
proposal.
• Once a week each plant would provide data to FSIS
to verify that the plant Is testing as required, and to
determine national trends.
January 1995
U.S. Department of Agrieullure
Food Safety & inspection Service
• FSIS continues to encourage meat and poultry plants
to put HACCP programs in place as soon as
possible.
• Under the proposal, plants that have HACCP
programs and that can show their products meet or
exceed the proposed targets and have verification
programs could request FSIS approval to use their
procedures instead of the proposed microbial
verification procedures.
For technical information, call
Richard Carnevale (202) 205-0675
January 1995
/ ■ - na/.tuu /^MiiiiyM^ iiiiu
y Critical Control Point
V - (HACCP) Systems
HACCP is a process control system designed to identify
and prevent microbial and other hazards in food
production and includes systematic steps to prevent
problems from occurring in the first place and correct
deviations as soon as they are detected.
USDA is proposing that all meat and poultry plants
implement HACCP systems. Preventive control
systems with documentation and verification are widely
recognized by scientific authorities and international
organizations as the most effective approach available
for producing safe food. Plants would be required to
develop HACCP plans to monitor and control their
operations. The FSIS HACCP proposal clearly defines
industry's responsibility for producing a safe,
wholesome, and unadulterated product. It also
emphasizes that FSIS' role is to verify that the meat
and poultry industries are meeting federal requirements
for food safety. FSIS will actively seek the ideas of
consumers, employees, scientists and industry.
• HACCP is accepted by scientific and food safety
authorities, such as the National Academy of
Sciences and the National Advisory Committee on
Microbiological Criteria for Foods, and international
organizations, such as the Codex Alimentarius
Commission and the lntei;national Commission on
Microbiological Specifications for Foods.
• FSIS is proposing to phase in HACCP throughout
the regulated industry over a 3-year period. Small
establishments would be phased in during the final
stage.
• The proposed regulations would also apply to foreign
countries that import meat and poultry products into
the United States.
• The HACCP system consists of seven principles that
plants must incorporate into their operation plans.
The seven principles include hazard analysis, critical
control point identification, establishment of critical
limits, monitoring procedures, corrective actions,
recordkeeping, and verification procedures.
• Principle No. 1 : Conduct a hazard analysis. Plants
identify the points in their food production process
where significant hazards could occur and describe
preventive measures that will be taken to keep
- hazards from occurring. HACCP does not address
quality issues.
• Principle No. 2 : Identify the critical control point
(CCP) in the process. A CCP is a point, step or
procedure at which control can be applied, and a
food safety hazard can be prevented, eliminated, or
reduced to an acceptable level.
• FSIS is proposing to require that processors in their
HACCP plans identify critical control points to
address and control all significant food safety
hazards — chemical, physical and biological,
including microbiological contamination.
• Examples of CCP's may include, but are not limited
to cooking, chilling, specific sanitation procedures,
antimicrobial treatments, product formulation control,
prevention of cross contamination, and certain
aspects of employee and environmental hygiene. All
CCP's must be carefully developed and documented.
• Principle No. 3 : Establish critical limits for preventive
measures associated with each identified CCP. A
critical limit is a criterion that must be met for each
preventive measure associated with a CCP.
• Critical limits must reflect relevant FSIS regulations,
FDA tolerances, and action levels, where
appropriate.
• Critical limits are most often based on process
parameters, such as temperatures, time, physical
dimensions, humidity, moisture level, water activity,
Ph, acidity, salt concentration and others, as well as
sensory information, such as texture, aroma, visual
appearance relating to the growth or survival of target
pathogens, chemical or physical hazards.
January 1995
U.S. Department of Agriculture
Food Saicly & Inspection Service
• Principle No. 4 : Establish CCP monitoring
requirements and establish procedures for using the
results of monitoring to adjust the process and
maintain control to meet a specified standard.
• Monitoring activities are necessary to ensure that
the process is in fact under control at each critical
control point.
• FSIS is proposing to require that procedures for
monitoring each critical control point be identified in
the HACCP plan, including ensuring that the
monitoring systems are capable of detecting process
deviations, such as product segregation and holding
procedures. The monitoring procedures must also
indicate the effect of deviations on product safety,
indicators for modification of the HACCP plan, and
the plant employee responsible for monitoring
activities.
• Monitoring may require materials or devices to
measure, test or otherwise evaluate the process at
critical control points.
• Principle No. 5 : Establish corrective actions to be
taken when monitoring indicates a deviation from
an established critical limit.
• Although the process of developing a HACCP plan
emphasizes preventive action, there is no guarantee
that problems will not arise.
• FSIS is proposing to require that meat and poultry
plants describe in their HACCP plans the corrective
actions that will be taken if a critical limit is not met.
Corrective actions must be specified in sufficient
detail to ensure that no public health hazard exists
after these actions have been taken.
• Principle No. 6 : Establish effective recordkeeping
procedures for the HACCP system.
• USDA is proposing to require that the HACCP plan
provide a recordkeeping system that will document
the processor's CCP monitoring, verification
activities, and deviation records.
• Principle No. 7 : Establish procedures for verifying
the HACCP system is working correctly. Verification
procedures may include, but are not limited to, review
of HACCP plan, CCP records, critical limits and
microbial sampling and analysis.
• FSIS is proposing to require that the HACCP plan
include a set of verification tasks to be performed by
plant personnel. Verification tasks would also be
performed by FSIS inspectors.
• It is envisioned that meat and poultry plants and FSIS
will undertake final product testing as one of several
verification activities.
• Verification links HACCP with the key element of the
FSIS regulatory strategy for pathogenic
microorganisms, which is the establishment of public
health-oriented targets, guidelines and standards
meat and poultry plants must meet to satisfy their
food safety responsibility.
For technical information, call
Dorothy Stringfellow (202) 690-2087
January 1995
Compliance
Schedule
The Food Safety and Inspection Service (FSIS) is
proposing new measures in inspection to target and
reduce the presence of pathogenic microorganisms in
meat and poultry products. These measures include
sanitation standards operating procedures,
antimicrobial treatments, time and temperature
controls, microbial testing and a mandatory Hazard
Analysis and Critical Control Points (HACCP) system
in all meat and poultry plants.
FSIS would use existing enforcement authority, when
necessary, to ensure that plants comply with new
requirements. FSIS will actively seek the ideas of
consumers, employees, scientists and industry on the
food safety proposal.
Proposals to be phased-in within 90 days
• Sanitation requirements - Plants would be
expected to have a written sanitation plan and keep
daily records documenting their adherence to it.
• Antimicrobial treatments - Slaughter plants would
have to start using a process to reduce harmful
bacteria on meat surfaces.
• Temperature controls - Plants would have to chill
raw product within specified timeframes and hold
products at temperatures that slow bacterial growth.
• For failure to comply with the three requirements,
plants could be subject to a range of enforcement
actions including: a) Being required to document
why the violation occurred and provide a plan to
prevent future violations; b) Having suspect product
retained until FSIS can decide whether it is safe or
can be made safe through further processing or
some other method; c) Having plant operation
delayed or inspection temporarily withheld — which
means the plant cannot operate; and d) completely
withdrawing inspection — which would permanently
close a plant.
• Microbial testing - Slaughter plants would begin
microbial testing 90 days after and tracking of test
results 6 months after the final rule is published. Two
years after publication of the final rule, plants would
have to meet USDA-set interim targets for pathogen
reduction.
• Plants not meeting these targets would be subject
to corrective action under FSIS supervision. This
would include submitting written reports on why they
are not meeting the target levels and how they plan
to correct that. Increased microbial testing could be
required to verify effectiveness of corrective
measures.
Proposals to be phased-in within 1 to 3 years
• Mandatory HACCP plans - Under the proposal, all
federally inspected meat and poultry slaughter and
processing plants would be required to develop and
implement a plant-specific HACCP plan within
specified timeframes. Foreign plants exporting
product to the United States and state inspected
plants would also be required to implement
equivalent HACCP plans.
• If a plant's HACCP plan is found invalid or
unacceptable, this would be considered evidence
that product produced may be unsafe and
appropriate regulatory actions would be taken to
protect public health.
For technical information, call
Bill Smith (202) 720-3697
January J 995
U.S. Dcparlmcnt of Agriculture
Food Safety & Inspection Service
International
Impact
To ensure meat and poultry products imported into the
United States are safe, wholesome and accurately
labeled, the same stringent requirements FSIS places
on the U.S. domestic industry are placed on foreign
countries exporting to this country.
Under the proposal, exporting countries would be
required to adopt the new pathogen reduction and
Hazard Analysis and Critical Control Points (HACCP)
measures in order to continue exporting their products
to the United States. FSIS will actively seek the ideas
of consumers, employees, scientists and industry on
its proposal.
• Through a comprehensive import inspection system,
FSIS determines the equivalence of foreign
inspection systems seeking to export product to the
United States.
• FSIS conducts reviews of foreign inspection systems
and plants and reinspects imported product at ports
of entry.
• FSIS determination of the equivalence of a foreign
country's inspection system centers on scientific and
risk assessment methodologies.
• The equivalence concept has been clarified by the
World Trade Organization (WTO) Agreement on
sanitary and phytosanitary measures.
• The Agreement emphasizes science as a
determinant of equivalence. All WTO member
countries have an obligation to apply the principle of
equivalence to export products to other member
countries.
• HACCP and other measures in the proposed rule
are examples of science identified in the WTO
definition of equivalence.
For technical information, call
Mark Manis (202) 720-3473
January 1995
U.S. Dcparlincnl of AgricullLirc
Food Safely & Inspcclion Service
Economic
Impact
Analysis
• <» IS • « • rA • ^ e » e « «
« a « 9 9 IS
The Food Safety and Inspection Service lias
determined tliat the implementation of Hazard Analysis
and Critical Control Points (HACCP) systems in meat
and poultry plants will minimize pathogen contamination
of meat and poultry products and lower the risk of
foodborne illness. FSIS conducted a regulatory impact
assessment on implementation of the proposed
pathogen reduction and HACCP systems. The
regulatory impact assessment concluded that the
• Over a three year period, the estimated cost to the
meat and poultry industry for developing,
implementing and operating the proposed pathogen
reduction and HACCP systems is estimated at
$733.5 million, averaging about $244.5 million per
year, or slightly more than 2/1 0 of a cent per pound
of meat and poultry.
• The estimate includes costs for near-term proposed
initiatives as well as the proposed long-term
HACCP intervention.
• The recurring cost after full implementation of the
pathogen reduction and HACCP systems is
estimated at nearly $231 million per year.
• The proposal would have a significant impact on
small plants, which are identified in the cost analysis
as plants having less than $2.5 million in annual
sales.
• There are about 6,200 federal slaughter,
processing, and combination slaughter and
processing plants, of which more than 2,200 or 36
percent are considered small federal plants.
• State-inspected plants also would be affected by
the pathogen reduction and HACCP systems.
There are nearly 2,900 state-inspected plants, and
they are all assumed to be small plants. Of the
more than 9,000 federal and state plants, about
5,100 or 56.5 percent are considered small plants.
HACCP proposal would yield an annual cost saving
for public health benefits of about $990 million to $3.7
billion because of reduced foodborne illness costs such
as medical care and lost worktime.
FSIS is publishing the Preliminary Regulatory Impact
Assessment along with the proposal and is actively
seeking comment on the assessment and proposal.
• The estimated costs over three years for small
plants to implement the proposed HACCP system
is $1 57.6 million. The estimated cost to small plants
for implementing near-term initiatives is about $1 73
million. The near-term initiatives would be put into
place 90 days after publication of the final
regulation.
• Plants that now have good processing controls are
expected to have relatively few implementation
costs to comply with the proposal. Plants with little
or no process controls would need to invest more
to comply.
• FSIS would allow small plants additional time to
meet proposed HACCP requirements. They would
have three years from the effective date of the
regulation to implement HACCP plans.
For technical information, call
Ed McEvoy (202) 205-0210
January 1995
U.S. Department of Agriculture
Food Safety & Inspection Service
I
i
!
I
i
Outreach
Activities
« « e • • • M
The Food Safety and Inspection Service has developed
a multi-faceted outreach strategy to inform, educate,
stimulate scientific discussion, and facilitate individual
and constituent group comments about the Pathogen
Reduction and Hazard Analysis and Critical Control
Point proposal during the proposal's 120-day comment
period. Outreach activities include various components
designed to ensure that consumers, industry,
constituent groups, and all other interested parties have
the opportunity to learn about the specifics of the
proposal and understand how it is intended to provide
for a safer meat and poultry supply. Constituent groups,
the public and other interested parties also will be able
to discuss and comment on issues addressed in or
related to the proposal.
Major components of the outreach effort include si>
information briefings on the proposal to be held in major
cities throughout the country; three scientific and
technical conferences to gain input from leading
scientific experts and others on specific issues in or
related to the regulatory proposal; a formal hearing to
facilitate public and constituent group comments on the
proposal; and employee outreach efforts.
Information Briefings
• Information briefings with questions and answers
sessions will be held 30 to 60 days into the comment
period in:
- Chicago
- Dallas
- San Francisco
- Atlanta
- New York
- Washington, D.C.
Scientific and Technical Conferences
• The following scientific and technical conferences
will take place 60 to 90 days into the comment period:
- New Technology to Improve
Food Safety — scheduled to be held in
Chicago.
- The Role of Microbiological Testing in
Ensuring Food Safety — to take place in
Philadelphia.
Public Hearing
• The public hearing will be held in Washington, D.C,
about 90 days into the comment period.
For more information, call:
Charles Danner (202) 501-7138
Andrew Moss (202) 720-7943
- Protecting Public Health Through Food
Safety Performance Standards — to be
held in Washington, D.C.
January 1995
U.S. Department of Agriculture
Food Safety & Inspeetion Service
!
f. FSIS Pathogen
Reduction/HACCP
Proposal
QUESTIONS AND ANSWERS
Q1. Why is FSIS making this proposal?
A1. Current FSIS regulatory requirements and
Inspection procedures contribute to the FSIS mission
of ensuring meat and poultry products are safe,
wholesome and accurately labeled. However, the
current program does not directly target pathogenic
microorganisms, which represent the largest public
health threat to consumers from meat and poultry. It
also does not make meat and poultry establishments
legally responsible for taking systematic, preventive
measures to reduce or eliminate the presence of
pathogenic microorganisms in meat and poultry
products.
To protect the public health and reduce the risk of
foodborne illness, FSIS is proposing to fill these gaps in
its current system by requiring new measures that would
target and reduce the presence of pathogenic
microorganisms in meat and poultry products. FSIS is
also beginning a fundamental shift in the paradigm
governing its inspection program. FSIS will begin to
build the principle of prevention into its inspection
program by proposing that all meat and poultry
establishments be required to adopt the Hazard Analysis
and Critical Control Point (HACCP) approach to
producing safe meat and poultry products.
Q2. What are the key elements of this
proposal?
A2. Within 90 days of publication of a final rule, the
proposal would require all establishments to develop
and keep written records of sanitation standard operating
procedures. Slaughter plants would be required to use
at least one antimicrobial treatment prior to chilling or
cooling. It would also require that meat and poultry
products reach optimal temperatures within specified
time periods to ensure maximum pathogen destruction.
Within a two-year timeframe, the proposal also calls for
reducing Salmonella in all meat and poultry products
by establishing interim targets and daily microbial testing
to ensure those targets are being met.
FSIS is also proposing that all meat and poultry
establishments develop and implement a HACCP
(Hazard Analysis and Critical Control Points) system.
FSIS anticipates that implementation of HACCP systems
would take place over a one to three-year time period.
Q3. How will sanitation procedures change
under this proposal?
A3. The sanitation SOP is a companion to the
proposed HACCP requirement and part of its foundation.
Like HACCP, the sanitation SOP reflects a commitment
by establishments to consistently control operations in
the interests of public health. The SOP demonstrates
that establishment owners know their operations and
how to keep them clean. Because products and
processes are different for each establishment, each
SOP, like each HACCP plan, may be unique.
The proposal does not affect existing basic sanitation
requirements found in the meat and poultry regulations
or the guidance on how to comply with these
requirements provided in the Sanitation Handbook and
other FSIS publications. Establishment owners would,
however, be required to describe in writing how they
are meeting those existing sanitation requirements in
their operations.
Q4. What antimicrobial treatments would be
permitted under this proposal?
A4. Antimicrobial treatments are interventions that
decrease microorganisms present on the surfaces of
meat and poultry carcasses. Those that have been
approved by FSIS include hot water or steam; lactic,
January 1995
U.S. Department of Agriculture
Food Safety & inspection Service
acetic and citric acid solution sprays; trisodium
phosphate (TSP); and chlorinated water. FSIS is
seeking comments on each of these treatments, as well
as any other antimicrobial treatment that can be proven
safe and effective.
Q5. What time and temperature require-
ments is FSIS proposing to establish?
A5. FSIS has concluded that most raw meat and
poultry products must be rapidly chilled and maintained
cold at 40 degrees F or below to minimize the risk to
public health from pathogens on those products. FSIS
is proposing that the surface of meat carcasses be
cooled to 50 degrees F or below within 5 hours and to
40 degrees F or below within 24 hours from the time
that carcasses exit the slaughter floor. Poultry
regulations would also be amended to be consistent.
Product that is not chilled quickly enough or that has
been held at temperatures exceeding 40 degrees F,
would be required to receive further processing to kill
pathogens or be condemned.
Q6. What interim targets are proposed for
Salmonella reduction?
A6. FSIS is proposing that, within two years or some
other period established by FSIS, all establishments
bring their incidence of Salmonella contamination below
the current national baseline incidence of Salmonella ,
perhaps by some specified percentage to be determined
during the rulemaking process. This can be done by
industry process controls and production practices that
have been demonstrated in actual practice as available
and effective for reducing the incidence of
microbiological contamination.
Each establishment would collect a minimum of one
sample for testing each day from each slaughter class
and/or class of raw ground product. The establishment
would record the results, which would then be used to
assess the effectiveness of a system over time.
Q7. Why was Salmonella chosen as the
target organism?
A7. Salmonella was selected for several reasons: 1 )
Salmonella is the leading cause of bacterial foodborne
illness in this country, and causes the greatest economic
2
burden; 2) FSIS baseline data suggest that Salmonella
is present in a variety of animals and birds in sufficient
numbers to detect and monitor frequency changes; 3)
current methodologies are available to recover
Salmonella from a variety of products; and 4) intervention
strategies aimed at reducing Salmonella may also have
an effect against other human enteric foodborne
pathogens.
Q8. When would HACCP be implemented?
Q8. FSIS envisions a phase-in of HACCP from 1 to 3
years, based on industry production process categories.
Small establishments — regardless of the processes
performed and products produced — would be given
the full three years for implementation. The FSIS
proposal identifies small plants as those plants having
less than $2.5 million in annual sales. FSIS is specifically
seeking comment on how to define "small"
establishments.
Q9. Does this proposal include any on-farm
activities?
A9. Not at this time. FSIS does not anticipate an on-
farm inspection role for Federal food safety inspectors.
FSIS will work with producers and others to develop
and foster implementation of food safety measures that
can be taken on the farm and prior to the animals
entering the slaughter facility to reduce the risk of harmful
contamination of meat and poultry products. This is
another specific issue area on which FSIS is seeking
comment.
Q10. How will FSIS address food safety
problems that occur after a meat or
poultry product leaves a federally
inspected establishment?
A10. FSIS and FDA share authority and responsibility
for overseeing the safety of meat and poultry products
after they leave FSIS-inspected facilities. FSIS and FDA
will review their respective programs to determine how
they can — considering all of the resources being
devoted to this sector — reconfigure the program or
initiate activities to increase program effectiveness. Two
specific areas of review will be transportation of product
in commerce and handling and preparation of food
products by retail stores, restaurants, and institutions.
In the area of transportation, FSIS is currently working
with FDA on the development of guidelines for
conveyances used to transport food products. In the
area of retail distribution, FSIS has worked closely with
FDA in the recent updating of the Food Code , a set of
model ordinances that serve as a guide for State and
local authorities who have primary responsibility for the
regulation of retail stores and restaurants. FSIS and
FDA will continue to work closely together to encourage
State adoption of the Food Code .
Q11. How would imported products be treated
as a result of these proposed
regulations?
A11. Foreign establishments exporting to the United
States will be required to adopt the pathogen reduction
measures and HACCP requirements FSIS imposes on
domestic establishments pursuant to this rulemaking.
As HACCP develops, FSIS will be considering what
effect adoption of HACCP should have on the nature
and frequency of import inspection.
Q12. How would the role of inspectors change
as a result of this proposal?
A12. Inspection of products and practices will remain
central to the FSIS inspection program. HACCP
verification would necessarily expand the roles of in-
plant inspectors, and HACCP would enhance the
contribution they can make to ensuring the safety of
food. FSIS has already begun working with its
inspectors' union and other employee organizations to
formulate a plan for the optimal use of inspectors for
each element of this proposal.
Industry costs to develop, implement, and operate
HACCP processing control systems are estimated at
$733.5 million over a three year period. However,
establishments that now have good processing controls
would have relatively few implementation costs, while
establishments that have little or no process control
would need to spend more for compliance. Further,
costs under the proposed regulation would manifest
themselves as investments in a more viable meat and
poultry industry, in contrast to the consumption
expenditures such as medical care, lost worktime, and
the other costs associated with foodborne illness.
Q14. Will this proposal make meat and poultry
safer for consumers?
A14. This proposal would build the public health
principle of prevention into the current meat and poultry
inspection system and directly target and reduce
contamination with dangerous bacteria. By reducing
the frequency of contamination of meat and poultry with
pathogenic microorganisms, these proposed
requirements would in turn reduce the risk of foodborne
illness from consumption of meat and poultry products.
There is no single technological or procedural solution
to the problem of foodborne illness, and the Agency's
food safety goal of reducing risk to the maximum extent
possible will not be achieved overnight. Food safety
requires continuous efforts to improve how hazards are
identified and prevented. This proposal reflects the
Agency's belief that steps that can be taken today to
reduce the risk of foodborne illness should be taken
today.
Q13. What are the costs and benefits of this
proposal?
A13. According to its Preliminary Regulatory Impact
Assessment, FSIS has concluded that mandating
HACCP systems would result in net benefits that far
exceed industry implementation and operation costs.
Mandatory HACCP implementation is projected to
produce a direct reduction in foodborne illness with
public health benefits estimated at $990 million to 3.7
billion annually.
3
Modernizing l^eat Inspection
by Mary Ann Parmley,
U.S. Department of Agriculture
Early in this century when the first
meat insp>ection acts were passed,
the science of public health was in
its infancy. Accordingly, meat
inspectors worked to keep diseased
animal products from reaching people's
tables. They accomplished that by visually
inspecting carcasses in meat plants.
Today, at the end of the century,
science has advanced miraculously, but
foodbome illness still poses a risk to the
American public. Statistics show that
millions of Americans contract foodbome
illness each year.
In far too many ways, though, USDA
inspectors continue to inspect meat and
poultry not much differently than their
counterparts did a himdred years ago—
that is, by sight, smell and touch.
But you can't "see" microscopic-sized
bacteria that cause food poisoning. USDA
is proposing a food safety initiative to
ensure that harmful bacteria levels in
products are substantially reduced as
soon as possible.
What are these proposed
changes all about?
While raw animal products will alwajrs
contain a number of bacteria and other
microbes (most harmless), this proposed
inspection plan dearly states that disease-
causing bacteria must be reduced to the
lowest levels possible.
This cannot be accomplished all at
once, but over the next 3 years, USDA
believes bacterial levels in plants can be
gradually reduced so as to greatly
minimize the threat of foodbome illness.
The proposal holds meat and poultry
producers legally responsible for making
these changes.
How the Proposal will work
USDA's ii«pectibn proposal consists of
three parts: 1) Immediate new in-plant
safeguards; 2) Immediate daily testing to
minimize bacteria in meat and poultry
foods; and 3) A requirement that every
plant set up a detailed HACCP plan.
HACCP stands for Hazard Anal)^is
Critical Control Point risk analysis.
1. In-plant safeguards
Soon after the new proposal becomes
effective, every meat and poultry plant
would operate under a sanitation plan
<^M^ MMt Product
Grooaiy
sun
USDA 's new proposal to protect you
and your family from farm to table
spedaUy designed to protect its products
from bacteria.
Plants would also be required to use
the most effective available anti-bacterial
rinses to dean disease agents off raw
meat surfaces. And they would be hdd
accountable for the proper cooling of raw
meat and poultry products.
2. Bacterial Testing
Let's say a hog plant produces pork
chops. Once a day, under this proposal,
the plant must test a hog carcass to see if
any of certain harmful bacteria are
present. This daily testing will establish a
performance profile for each plant that
shows their success at reaching national
bacteria reduction targets.
Over the first 2 years, USDA will work
dosely with plants to refine testing,
process control and reporting procedures
necessary to lower bacteria levels. After
that, all plants producing raw product
would be required to meet USDA-set
national targets for bacterial reduction.
inspection that Protects
To move meat and poultry inspection
into the 21st century, we must directiy
target the bacteria that make people
sick and use the tools of sdence to
systematically prevent food safety
problems.
Michael R. Taylor, USDA,
Acting Under Secretary for Food Safety
3. HACCP plans
The first two parts of the proposal — ^new
sanitary requirements eind otiier safe-
guards plus bacteria testing — ^would go
into effect right away. But they just set the
stage for USDA's major shift, and that is
to require that within 3 years every plant
operate imder a detailed, carefully
researched HACCP or risk prevention
plan covering every step in production.
HACCP analysis requires plant manag-
ers to identify every p>oint in production
where something coiild go wrong to
jeopeirdize product safety. The HACCP
plan cilso spells-out precise corrective
actions to be taken.
Furthermore, HACCP-type safeguards
would be extended beyond the meat or
poultry plant back to ti\e farm and
forward through transportation and safe
handling at the store or other retail outlet.
In this ^ort, USDA will work with meat
and poultry producers, transporters,
retail sales people and offidaJs with local
jurisdiction.
The Consumer Role
Of course the safe handling of raw meat
and poultry products cannot end at the
plant or grocery store door. No matter
how safe government and industry try to
make meat food products, the last, best
line of defense against foodbome illness
is still safe handling at home.
Consiuners should read and routinely
follow the guidelines on the new safe
handling labels on meat and poultry.
Safe Handling off Meat &
Poultry means
1. Keep it refrigerated or frozen. Thaw in
refrigerator or microwave.
2. Keep raw meat cind poultry separate
from other foods. Wash work surfaces
(induding cutting boards), utensils
cmd hands after touching raw meat or
fKJultry.
3. Cook thoroughly.
4. Keep hot foods hot. Refrigerate left-
overs immediately or discard. *
For more information on USDA's new Proposed
Regulation to Improve Meat and Poultry Inspection or
the everyday safe handling of meat and poultry
products, call the Meat and Poultry Hotline. 800-535-
4555. Washington. D.C. residents call 202-720-4333.
USDA is strengthening
inspection for safer
meat & poultry products
To move ahead with the most comprehensive
improvements in meat and poultry inspection in a
hundred years, USDA's new food safety initiative calls for.
SOURCE: U. S. Department of Agriculture
i
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